Eunice Kennedy Shriver NICHD Cooperative Multicenter Neonatal Research Network

尤尼斯·肯尼迪·施赖弗 (Eunice Kennedy Shriver) NICHD 合作多中心新生儿研究网络

• 批准号: 9898411
• 负责人: CHARLES Michael COTTEN
• 金额: $ 27.88万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-05-01 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9898411
• 关键词: Active Sites; Address; Administrative Supplement; Affect; Antibiotics; Autologous; BDNF gene; Biomedical Engineering; Blood Cells; Brain Injuries; Bronchopulmonary Dysplasia; Budgets; Candida; Candidiasis; Cell Therapy; Childhood; Chromosome 8; Clinic; Clinical; Clinical Data; Clinical Research; Clinical Trials; Clinical Trials Network; Cohort Studies; Communicable Diseases; DNA Library; Databases; Dedications; Delivery Rooms; Development; Early Diagnosis; Enrollment; Ensure; Environment; Faculty; Fostering; Funding; Future; Genes; Genetic Variation; Genetic study; Goals; Gold; Health; Health system; Healthcare; Infant; Infant Care; Inositol; Institution; Institutional Review Boards; Interdisciplinary Study; Intervention; Investigation; Lead; Link; Low Birth Weight Infant; Medical; Medical center; Mentors; Methodology; Molecular; Morbidity - disease rate; Multicenter Neonatal Research Network; National Institute of Child Health and Human Development; Necrotizing Enterocolitis; Neonatal; Neonatal Intensive Care; Neonatology; Neurodevelopmental Impairment; Newborn Infant; North Carolina; Obstetric Delivery; Outcome; Paper; Patent Ductus Arteriosus; Pathway interactions; Patients; Perinatal; Phosphorylases; Pregnancy; Premature Infant; Protocols documentation; Psychologist; Publications; Publishing; Recording of previous events; Reporting; Research; Research Institute; Research Personnel; Resources; Retinal Diseases; Retinopathy of Prematurity; Risk; Role; Sampling; Scientist; Site; The science of Mycology; Time; Transfusion; Umbilical Cord Blood; United States National Institutes of Health; Universities; Validation; Variant; Vulnerable Populations; career; career development; clinical center; clinical research site; cohort; data warehouse; disability; experience; extreme prematurity; follow-up; genetic association; genetic epidemiology; genetic variant; genome-wide; improved; improved outcome; infant outcome; innovation; interdisciplinary approach; intraventricular hemorrhage; late onset sepsis; medical schools; mortality risk; multidisciplinary; neonatal encephalopathy; novel; patient population; pediatric department; phase 3 study; phase III trial; premature; prospective; public health relevance; risk variant; skills; study population; tool; working group

 DESCRIPTION (provided by applicant): The Duke University School of Medicine, Division of Neonatology enthusiastically submits this renewal application for a fourth consecutive cycle of participation in the Eunice Kennedy Shriver NICHD-sponsored Cooperative Multicenter Neonatal Research Network (NRN). The NRN's purpose is to perform interventional and observational clinical studies in newborn infants, particularly those of low birth weight or gestation, that lead to improved medical and neurodevelopmental outcomes. Duke's aims in support of the NRN are to: 1) prioritize and conduct approved NRN protocols while maintaining a > 90% follow-up rate; 2) bring innovative, collaborative multidisciplinary research opportunities to the NRN; 3) introduce young faculty to NRN mentoring opportunities to foster new ideas and ensure ongoing progress in Neonatal Intensive Care. In support of these aims Duke added two satellite sites. In January 2009, Duke was the first Network site to add an independent academic institution when the University of North Carolina at Chapel Hill (UNC) joined Duke. WakeMed Medical Center was added in July 2014. The addition of UNC and WakeMed expands the study population and enhances the Site's clinical trial expertise. It also increases the impact of NRN studies on neonatal health care in our region and State. The Duke Site (Duke, UNC, WakeMed) leads enrollment in the NRN Inositol phase III trial and is among the highest enrolling sites in th Network's Generic Database and Transfusion for Prematures studies. Duke, UNC, and WakeMed maintain multidisciplinary follow-up clinics which maintain follow-up rates for clinical trials and cohort studies > 90%. Duke leads two major Network projects, "Early Diagnosis of Neonatal Candidiasis" and the "Anonymized DNA Bank", that combined Duke' expertise in Infectious Diseases, Medical Mycology, Biomedical Engineering, Genetic Epidemiology and Molecular Methodologies. Candida trial materials continue to be analyzed and have provided information that has likely contributed to the decrease in Candidiasis. The DNA bank samples and linked clinical data have been used to identify associations between variants in phosphorylase pathway genes and BPD risk, and variants in the BDNF gene and severe retinopathy. This year at PAS NRN investigators reported associations between variants in an intragenic region on chromosome 8 and severe NEC that reached genome wide significance. The Bank's data has also been used as a validation cohort for other NIH-funded investigations of genetic associations with morbidities of prematurity. In addition to these two studies which have produced resources still being used by investigators from multiple sites, Duke has made involvement of junior faculty and trainees in the NRN. Eight different Duke Site investigators have co-authored 38 NRN papers published in the last cycle (8 first-author papers). Duke, UNC, and WakeMed will continue efforts to maximize enrollment and maintain follow-up for cohort studies and clinical trials > 90%. Innovative studies of cell therapy for brain injury and management strategies for Patent Ductus Arteriosus (PDA trial) have been reviewed by the NRN and are likely to begin in the 2016 - 2021 cycle. The PDA protocol is led by Dr. Laughton (UNC). The autologous cord blood study for infants with neonatal encephalopathy (Cotten) was presented as an NRN concept in January 2015, and approved to be developed into a full protocol for NRN consideration. The Duke Site will continue these efforts plus bring additional novel concepts for clinical trials. The Duke, UNC, and WakeMed Departments of Pediatrics, and the Health Systems fully support our ongoing collaborative commitment to the NRN, as we firmly believe that our interactions with the NRN have directly affected and improved the care of infants in our three institutions and throughout our State.

 描述（由申请人提供）：杜克大学医学院新生儿科热情地提交了这份连续第四个周期参与尤尼斯·肯尼迪·施赖弗 NICHD 赞助的合作多中心新生儿研究网络 (NRN) 的申请。 NRN 的目的是。对新生儿（特别是低出生体重或妊娠期的婴儿）进行介入和观察性临床研究，以改善医学和神经发育结果，以支持杜克大学的目标。 NRN 将：1) 优先考虑并实施经批准的 NRN 方案，同时保持 > 90% 的随访率；2) 带来创新、协作的多学科研究机会； 3) 为年轻教师提供 NRN 指导机会，以培养新想法并确保新生儿重症监护不断取得进展 为了支持这些目标，杜克大学于 2009 年 1 月添加了两个卫星站点。北卡罗来纳大学教堂山分校 (UNC) 于 2014 年 7 月加入 WakeMed 医学中心时成为独立的学术机构。 UNC 和 WakeMed 的加入扩大了研究人群并增强了该中心的临床试验。它还增加了 NRN 研究对我们地区和州新生儿保健的影响 杜克大学网站（杜克大学、北卡罗来纳大学、WakeMed）在 NRN 肌醇 III 期试验中处于领先地位，并且是 th Network 的通用注册网站之一。早产儿研究数据库和输血。杜克大学、北卡罗来纳大学和 WakeMed 维持多学科随访诊所，维持临床试验和队列研究的随访率 > 90%。 “新生儿念珠菌病的早期诊断”和“匿名 DNA 库”结合了杜克大学在传染病、医学真菌学、生物医学工程、遗传流行病学和分子念珠菌试验材料方面的专业知识，并继续进行分析，并提供了可能有所贡献的信息。 DNA 库样本和相关临床数据已用于确定磷酸化酶途径基因变异与 BPD 风险之间的关联，以及 BPD 风险的变异。 BDNF 基因与严重视网膜病变。今年，PAS NRN 研究人员报告了 8 号染色体基因内区域的变异与严重 NEC 之间的关联，该关联已达到全基因组范围的显着性，该数据也被用作 NIH 资助的其他研究的验证队列。除了这两项研究提供的资源仍被多个研究中心的研究人员使用外，杜克大学还让 NRN 的八名不同的杜克大学研究人员参与了研究。上一周期发表的 38 篇 NRN 论文（8 篇第一作者论文）将继续努力最大限度地提高入组率并维持细胞创新研究的随访率 > 90%。脑损伤的治疗和动脉导管未闭的管理策略（PDA 试验）已由 NRN 审查，并可能在 2016 年至 2021 年周期开始。 PDA 方案由以下机构领导。 Laughton 博士（北卡罗来纳大学）。2015 年 1 月，针对患有新生儿脑病 (Cotten) 的婴儿的自体脐带血研究作为 NRN 概念提出，并被批准开发为完整的方案供 NRN 考虑，杜克大学站点将继续这些努力。此外，杜克大学、北卡罗来纳大学和 WakeMed 儿科以及卫生系统完全支持我们对 NRN 的持续合作承诺，因为我们坚信我们与 NRN 的互动。 NRN 直接影响和改善了我们三个机构和整个州的婴儿护理。